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CompletedNCT04301037Updated Mar 9, 2020

Tension Band Wiring Versus Cannulated Screws in Fixation of Medial Malleolus in Ankle Fracture

An interventional study of Tension band wires and Cannulated screws in Medial Malleolus Fracture, sponsored by Hawler Medical University. Completed at 1 site in Iraq. Open to participants aged 20 Years to 55 Years. Per ClinicalTrials.gov, last updated 2020-03-09.

Sponsored by Hawler Medical University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 11 months after the study started (first participant enrolled Apr 2018, registered Mar 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
20 Years to 55 Years
Sex
All
01

Study summary

This is a prospective randomized study conducted on 30 patients with an age spanning between 20 and 55 years. Half of the sample was treated by tension band wiring for closed medial malleolar fractures, and the other half by two cannulated screws. The patients were assessed at (6w-3months and 6months) for clinical and radiological union and evaluated functionally (12 months) using modified Olerund and Molander scoring system.

02

Conditions studied

  • Medial Malleolus Fracture

Keywords

  • Fixation of medial malleolus
  • Tension band
  • Malleolus fracture
  • Ankle fracture
03

In context

Fractures, Bone

2,261 studies on the registry are indexed under Fractures, Bone; 325 are open to participants now.

This study's enrollment of 60 is below the median of 69 across 1,482 interventional studies indexed under Fractures, Bone.

Browse Fractures, Bone studies →

Lead sponsor

Hawler Medical University is the lead sponsor of 56 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Patients aged from 20-55 years.
  2. Isolated or bimalleolar ankle fractures.
  3. Closed fractures.

Exclusion criteria

Exclusion Criteria:

  1. Patient with poor bone quality on x ray (radiological osteopenia, thinning of the cortices, loss of trabecular definitions and previous insufficiency fractures)
  2. Type D isolated medial malleolus, supination adduction (vertical malleolar) fractures.
  3. Comminuted fractures.
  4. Skeletally immature patients.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • Active comparator
    Tension band wiring

    This group was treated by k-wires fixation and tension band wiring

    Procedure: Tension band wires

  • Active comparator
    Cannulated screws

    This group was treated by 2 cannulated screws

    Procedure: Cannulated screws

Interventions

  • ProcedureTension band wires

    medial malleolus fracture fixed with tension band wiring): 2 k.wires (1.6 mm) are inserted perpendicular to the fracture site. Again the position is checked under image intensification for the correct direction and length. We drilled a 2.5mm hole with a protection sleeve, 2-3cm above the level of the horizontal joint line, aiming the drill bit slightly inferiorly to avoid screw pullout. We inserted a 3.5mm unicortical screw about 30 mm in length (with or without washer), 2-3mm is left for the wire between the bone and screw head before full tightening. A steel wire is constructed into a figure of eight between the screw the reduction k. wires, then twisted to achieve interfragmentary compression

  • ProcedureCannulated screws

    In group 2 (15 patients with medial malleolus fixed by 2 cannulated screws): Two guide wires (1.6mm) are inserted perpendicular to the fracture site, the appropriate length, proper insertion site including the distance from the articular surface is checked fluoroscopically .the length is measured .drilling of the bone through the threaded guide wire with a cannulated drill bit (3.2mm). A two 4.5mm partially threaded cannulated screws (with or two washers) are inserted through the guide to achieve Compression, the guide wires are then removed

06

What researchers measure

Primary outcomes

  1. Modified Olerund and Molander scoring system

    Ankle functional outcome

    Time frame: The functional outcome was measured in all patient 12 months after surgery

07

Study locations

1 site
  • Sherwan Hamawandi
    Erbil, 44001, Iraq
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 9, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04301037
Lead sponsor
Hawler Medical University
Responsible party
Sherwan Ahmed Ali Hamawandi (Assistant professor of orthopedic surgery, Hawler Medical University) — Principal investigator
First posted
Mar 9, 2020
Start date
Apr 1, 2018
Primary completion
Aug 1, 2019
Completion
Aug 30, 2019
Last update
Mar 9, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

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